SOP Appendices

SOP reference number and title
Appendix title 
S-1002 UoL Initial Documentation Review Process

Appendix 1.1 Sponsorship Application Form - for all studies excluding data studies (Word, 101kb)
Appendix 1.2 Sponsorship Application Form - for data studies (Word, 63 kb)
Appendix 2 Sponsor Peer Review Form (Word, 56 kb)

S-1003 Sponsor Risk Assessment and Management of Research Appendix 1 Risk Assessment Form
Appendix 2 Sponsor Review Risk Assessed Studies
Appendix 3 Sponsor Review Non-risk Assessed Studies
Appendix 4 Risk Assessment Flow Chart
S-1007 Site Management (Monitoring) for University of Leicester when Acting as Sponsor
Appendix 1 Monitoring Plan Template
Appendix 2 Monitoring Strategy Table
Appendix 3 Trial Monitoring Visit Log
Appendix 4 Template Source Data Agreement
Appendix 5 Monitoring Visit Report and Response Document
Appendix 6 Contact Monitoring Log
Appendix 7 Non-CTIMP Interim Site Audit checklist and Response
S-1009 Processing and Reporting of Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions
Appendix 1 Pregnancy Reporting Form
Appendix 2 Multicentre Non-CTIMP Line Listing
Appendix 3 SAE Listing Table
Appendix 4 SAE Review Process Flowchart
Appendix 5 Template Sponsor SAE Email
Appendix 6 Multicentre CTIMP Line Listing
SAE Reporting Form A CTIMP
SAE Guidelines Form A
SAE Reporting Form B Non-CTIMP
SAE Guidelines Form B
S-1010 Chief Investigator Responsibilities
Appendix 1 UoL Roles and Responsibilities of CI Agreement
S-1011 Site Initiation for Clinical Trials of Investigational Medicinal Products Research

Appendix 1 Site Initiation Checklist and Outstanding Issues
Appendix 2 Pharmacy Site Initiation Visit Checklist and Outstanding Issues
Appendix 3 SOP Read Log
Appendix 4 Site Initiation Visit Log
Appendix 5 Screening Log
Appendix 6 Subject Enrolment Log
Appendix 7 Non-CTIMP Site Initiation Checklist
Non CTIMP SIV Checklist Guidance Document

S-1012 Management and Production of Corrective And Preventative Action plan (CAPA) for Studies
Appendix 1 CAPA form
S-1013 Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Trials
Appendix 1 Serious Breach Notification Form
Appendix 2 Protocol Deviation Tracking Log
S-1014 Development Safety Update Report for Clinical Trials of Investigational Medicinal Product Studies Appendix 1 DSUR Template
Appendix 2 DSUR Reporting Timeframe Working Illustration
Appendix 3 DSUR Reporting Timeframe Working Instructions
S-1015 Creating and Maintaining a Trial Master file (TMF) or Investigator Site File (ISF) Appendix 1 TMF/ISF Contents CTIMP
Appendix 2 TMF/ISF Contents Non-CTIMP
Appendix 3 Version Control Tracker
S-1017 Process for Application for Indemnity
Appendix 1- Indemnity Flowchart
S-1020 Training for Staff Engaged in Research
Appendix 1 Protocol Training Log
S-1021 Informed Consent

Appendix 1 Delegation of Authority and Signature Log
Appendix 2 Assent Authority and Signature Log
Appendix 3 Assent Consent Log 
Appendix 4 Pre-Consent activity proforma
Appendix 5 Witness Consent Form Template
Appendix 6 Consent Witness Statement

S-1023 Investigator’s Brochure Preparation, Review and Approval Appendix 1 IB Contents Template
Appendix 2 IB Review Template
S-1024 Study Closedown and End of Study Reporting Appendix 1 Site Closedown Checklist CTIMP Studies
Appendix 2 UoL Site Close Down Visit Log
Appendix 3 Site Closedown Checklist non-CTiMP Studies
S-1025 Sponsor Green Light Process Appendix 1 Sponsor Green Light Review Process Flowchart
Appendix 2 Sponsor Green Light - Green Light Process First Site
Appendix 3 Sponsor Green Light - Multi Centre Site Sponsor Green Light
Appendix 4 Sponsor Green Light Contracts - Agreements Listings
S-1026 Sponsor Green Light Process Appendix 1 Amendments for MHRA
Appendix 2 Amendments for MHRA and REC
Appendix 3 Amendments for REC
Appendix 4 Amendments not requiring notification
Appendix 5  Multi Centre Site Sponsor Green Light
Appendix 6 Green Light Process First Site
S-1027 Process for Writing Protocols 

Non-CTIMP Protocol Template
Data Only Protocol Template

S-1028 Convening a Data Safety Monitoring Committee
Appendix 1 Data Safety Monitoring Committee Charter
S-1029 Urgent Safety Measures
Appendix 1 Urgent Safety Measures Template
S-1032 Archiving of Essential Documents
Appendix 1 Archiving Facility Checklist
Appendix 2 Archiving Electronic Aspects of TMF
Appendix 3 Archive Process Checklist
Appendix 4 Archiving process flowchart
Appendix 5  Retrieval process flowchart
Form A
Form B
Form C
S-1033 Process for Assessing Site Feasibility Appendix 1 Site Feasibility Assessment
Appendix 2 Site Feasibility Assessment Pharmacy
S-1034 Inclusion of Incapacitated Adults in Research Studies Appendix 1 Conditions & Principles which apply Inclusion of an Incapacitated Adult
Appendix 2 S-1034 Incapacitated Adults Nomination Form
S1039 Case Report Form Production
Appendix 1 Case Report Form Template
Appendix 2 Guide to designing a CRF
S-1040 Finance Process
Appendix 1 Finance Process
S-1041 Management of Healthy Volunteers in Research Studies of the Bioequivalence, Pharmacokinetics (PK) or Pharmacodynamics (PD) of Investigational Medicinal Products
Appendix 1 TOPS Consent Template
S-1042 Process for Sample Management Appendix 1a  FRIDGE Temperature  Log
Appendix 1b FREEZER Temperature Log
Appendix 1c NITROGEN Log
Appendix 2 Sample Tracking Log
Appendix 3 Sample End of Study Sponsor Form
Appendix 4 Shipping Instructions for Biological Samples
S-1043 Medical Device Studies Safety Reporting  Appendix 1 Event Categorisation Flow Chart
Appendix 2 Adverse event Adverse Effect record
Appendix 3 SAE Report Form C
Appendix 4 SAE Form C Completion Guidance Document
Appendix 5 MHRA Device Reporting Form
Appendix 6 Medical Device Sponsor Process Flowchart
Appendix 7 Template  SAE SADE Follow Up Information Request   Email
S-1050 Pandemic Research Appendix 1 Pandemic Research Risk Assessment Form
Appendix 2 Pandemic Site File Note